NCT07215182 [68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
| NCT ID | NCT07215182 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Barbara Malene Fischer |
| Condition | Malignant Melanoma Stage IV |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2026-08-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-08-15 with a primary completion date of 2026-08-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to investigate the use of the tracer \[68Ga\]Ga-FAPI-46 for PET/CT-imaging in response evaluation of patients with advanced stage malignant melanoma treated with immune checkpoint inhibitor therapy (ICT). The main question it aims to answer is: • Can \[68Ga\]Ga-FAPI-46 PET/CT improve response evaluation in patients suffering from advanced stage malignant melanoma treated with ICT and potentially serve as a biomarker. Researchers will compare findings on the experimental \[68Ga\]Ga-FAPI-46 PET/CT with findings on standard imaging (\[18F\]FDG PET/CT). Participants will undergo: * Two \[68Ga\]Ga-FAPI-46 PET/CT scans: one before treatment initiation with ICT and one after three months. * Two blood samples * Passive follow-up 6 months after the last scan \[68Ga\]Ga-FAPI-46 PET/CT
Eligibility Criteria
Inclusion Criteria: 1. Male or female, \>/=18 years old 2. Histological verified metastatic or locally advanced malignant melanoma 3. Visible malignant lesions on \[18F\]FDG PET/CT or CT 4. Subjects must be considered inoperable 5. Subjects must be considered medically suitable for ICT 6. Subjects must be able to read and understand the patient information in Danish to give informed consent Exclusion Criteria: 1. Ocular or mucosal melanoma 2. Other concurrent cancer disease 3. Previous systemic oncological treatment with ICT 4. Pregnancy or lactation 5. Weight more than the maximum limit of a PET/CT-scanner bed (140 kg) 6. History of allergic reaction due to compounds similar to the chemical composition of \[68Ga\]Ga-FAPI- 46
Frequently Asked Questions
Who can join the NCT07215182 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Melanoma Stage IV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07215182 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07215182 currently recruiting?
Yes, NCT07215182 is actively recruiting participants. Visit ClinicalTrials.gov or contact Barbara Malene Fischer to inquire about joining.
Where is the NCT07215182 trial being conducted?
This trial is being conducted at Herlev, Denmark, Copenhagen, Denmark.
Who is sponsoring the NCT07215182 clinical trial?
NCT07215182 is sponsored by Barbara Malene Fischer. The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.